Vitamin/Mineral Supplement for Children and Adults With Autism

This study has been completed.
Sponsor:
Collaborators:
Autism Research Institute
Legacy Foundation
Information provided by:
Arizona State University
ClinicalTrials.gov Identifier:
NCT01225198
First received: September 14, 2010
Last updated: October 19, 2010
Last verified: October 2010
  Purpose

The investigators hypothesis is that a new, revised formulation of a vitamin/mineral supplement will result in:

  1. improvement of nutritional status in some children/adults with autism, and
  2. reduction of some of the symptoms of autism in some children

Condition Intervention Phase
Autism
Dietary Supplement: Multi-Vitamin/Mineral Supplement
Other: Liquid Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: New Vitamin/Mineral Supplement for Children and Adults With Autism - National Study

Resource links provided by NLM:


Further study details as provided by Arizona State University:

Primary Outcome Measures:
  • Oxidative Stress [ Time Frame: Beginning of study (day 0) ] [ Designated as safety issue: Yes ]
    Level of Plasma Nitrotyrosine

  • Oxidative Stress [ Time Frame: End of Study (after 12 weeks of treatment) ] [ Designated as safety issue: Yes ]
    Level of plasma nitrotyrosine


Secondary Outcome Measures:
  • Parent Global Impressions - Revised [ Time Frame: End of study (12 weeks) ] [ Designated as safety issue: Yes ]
    The Average Change of the Parent Global Impressions (PGI-R) assessment tool.


Enrollment: 143
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Group
Liquid placebo with identical packaging and flavoring to the real supplement.
Other: Liquid Placebo
The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).
Experimental: Vitamin/Mineral Supplement Group
Multi-vitamin/mineral supplement designed for this study for children and adults with autism spectrum disorders.
Dietary Supplement: Multi-Vitamin/Mineral Supplement
A broad-spectrum vitamin/mineral supplement designed for children and adults with autism

Detailed Description:

The major goal of this study is to determine the effect of this vitamin/mineral supplement on levels of vitamins, minerals, neurotransmitters, and biomarkers for nutritional deficiencies. The study design is a randomized, double-blind, placebo-controlled. Blood and urine measurements will be measured at the beginning of the study in children with autism and typical children. Then, the children with autism will be given the supplement or placebo for 12 weeks, and then their blood and urine will be re-measured.

  Eligibility

Ages Eligible for Study:   3 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. age 3-60 years old;
  2. Autism Group: diagnosis of autism, pervasive developmental disorder/not otherwise specified (PDD/NOS), or Asperger's by a psychiatrist or similar professional
  3. Control Group: in good mental and physical health, and no siblings with autism spectrum disorders, and no evidence of Attention Deficit Disorder by parent report

Exclusion Criteria:

  1. Usage of a vitamin/mineral supplement in the last 2 months
  2. Current use of any chelation treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225198

Locations
United States, Arizona
Arizona State University
Tempe, Arizona, United States, 85287
Sponsors and Collaborators
Arizona State University
Autism Research Institute
Legacy Foundation
Investigators
Principal Investigator: James B. Adams, PhD Arizona State University
  More Information

Additional Information:
No publications provided by Arizona State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James B. Adams, Arizona State University
ClinicalTrials.gov Identifier: NCT01225198     History of Changes
Other Study ID Numbers: AutismVitaminStudy2008
Study First Received: September 14, 2010
Last Updated: October 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Arizona State University:
Vitamins
Minerals

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014